# FDA 483 - Brian R. Davis, MD - May 16, 2019

Source: https://www.keypedia.com/records/483/brian-r-davis-md/0f7f3b86-f17a-4a19-a69f-1a4f82240dae

> FDA 483 for Brian R. Davis, MD on May 16, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Brian R. Davis, MD
- Inspection Date: 2019-05-16
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Brian R. Davis, MD, a clinical investigator in El Paso, TX, revealed significant deviations from the signed statement of investigator and failures in maintaining adequate case histories for a clinical study. These issues indicate a lack of adherence to protocol and proper documentation practices, impacting the integrity of the study data. The inspection identified problems with subject enrollment, adverse event reporting, delegation of informed consent, and missing laboratory results and other critical data.

## Related Officers

- [Jonathan R. Campos](https://www.keypedia.com/people/jonathan-r-campos/f4c6aba7-d0fe-43d2-95ae-5eb86a6659a4)

Company: https://www.keypedia.com/companies/brian-r-davis-md/f08d98b8-0dd7-4d16-b5e6-726d284221ae

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9